Intervascular Post-Market Clinical Follow-Up (PMCF) Registry

Официальное название

Post-Market Clinical Follow-up Registry to Evaluate the Safety and Performance of the Intervascular Vascular Grafts and Patches in Patients Undergoing Bypass, Replacement, or Repair of Aortic, Peripheral, or Carotid Arteries

Обзор

The purpose of this registry is to evaluate the long-term safety and performance of Intervascular Vascular Grafts and Patches (Intergard Standard, Hemashield, Intergard Silver, Intergard Synergy) for bypass, repair or replacement of aortic, peripheral, or carotid arteries. This registry is intended to further define the expected product lifetime of the devices and to collect data related to usefulness of the antimicrobial coatings.

Вмешательства

• Устройство Intergard Standard - Collagen Coated Vascular Grafts and Patches
  Intergard Standard, Collagen coated vascular grafts and patches are made of knitted (knitted or knitted ultrathin) or woven polyester. The products are coated with a highly purified form of cross-linked bovine collagen to minimize intraoperative bleeding and eliminate the need for preclotting at the time of implant. Note that the radially supported grafts have a polypropylene supportive coil designed to resist kinking and compression of extra-anatomical vascular repair, where potential unwanted
• Устройство Hemashield - Collagen Coated Vascular Grafts and Patches
  Hemashield Vascular Grafts and Patches are made of knitted or woven polyester. The products are impregnated with a highly purified bovine collagen to reduce bleeding at the time of implant and thereby eliminates the operative preclotting step.
• Устройство Intergard Silver - Antimicrobial Collagen Coated Vascular Grafts and Patches
  Intergard Silver antimicrobial collagen coated vascular grafts are made of knitted (knitted or knitted ultrathin) or woven polyester. The Hemapatch Silver Ultrathin is a surgical patch made from knitted ultrathin polyester fabric. The products are coated with a highly purified form of cross-linked bovine collagen to minimize intraoperative bleeding and eliminate the need for preclotting at the time of implant. In addition to collagen coating, the collagen matrix of Intergard Silver vascular graf
• Устройство Intergard Synergy - Antimicrobial Collagen Coated Vascular Grafts
  Intergard Synergy antimicrobial collagen coated vascular grafts are made of knitted (knitted or knitted ultrathin) polyester. The products are coated with a highly purified form of cross-linked bovine collagen to minimize intraoperative bleeding and eliminate the need for preclotting at the time of implant. In addition to collagen coating, the collagen matrix of Intergard Synergy Antimicrobial collagen coated vascular grafts is loaded with antimicrobial agents: silver acetate and triclosan. The

Первичные конечные точки

• Peripheral Arterial Disease Cohort: Cohort: Percentage of participants meeting primary device patency [Срок оценки: Procedure/surgery through registry completion, anticipated average of 5 years]
• Aortic Disease Cohort: Percentage of participants meeting primary device patency [Срок оценки: Procedure/surgery through registry completion, anticipated average of 5 years]
• Carotid Artery Disease Cohort: Percentage of participants achieving freedom from occlusion or reintervention [Срок оценки: Procedure/surgery through registry completion, anticipated average of 5 years]
• Peripheral Arterial Disease Cohort: Incidence of Major Adverse Limb Events (MALE) [Срок оценки: Procedure/surgery through registry completion, anticipated average of 5 years]
• Aortic Disease Cohort: Incidence of Major Adverse Event (MAE) [Срок оценки: Procedure/surgery through registry completion, anticipated average of 5 years]
• Devices with antimicrobial coating: Percentage of participants achieving freedom from infection [Срок оценки: Procedure/surgery through registry completion, anticipated average of 5 years]
• Carotid Artery Disease Cohort: Incidence of Major Adverse Event (MAE) [Срок оценки: Procedure/surgery through registry completion, anticipated average of 5 years]

Вторичные конечные точки (9)

• All cohorts: Percentage of participants achieving technical success [Срок оценки: Procedure/surgery through registry completion, anticipated average of 5 years]
• All cohorts: Incidence of reported complications and events [Срок оценки: Procedure/surgery through registry completion, anticipated average of 5 years]
• All cohorts: Incidence of infection [Срок оценки: Procedure/surgery through 30 days]
• Peripheral Arterial Disease Cohort: Percentage of patients meeting primary-assisted device patency [Срок оценки: Procedure/surgery through registry completion, anticipated average of 5 years]
• Peripheral Arterial Disease Cohort: Percentage of patients meeting secondary device patency [Срок оценки: Procedure/surgery through registry completion, anticipated average of 5 years]
• Peripheral Arterial Disease Cohort: Rate of change in Rutherford Category [Срок оценки: Procedure/surgery through registry completion, anticipated average of 5 years]
• Peripheral Arterial Disease Cohort: Rate of change in Ankle-Brachial Index [Срок оценки: Procedure/surgery through registry completion, anticipated average of 5 years]
• Aortic Disease Cohort: Percentage of patients meeting primary-assisted device patency [Срок оценки: Procedure/surgery through registry completion, anticipated average of 5 years]
• Aortic Disease Cohort: Percentage of patients meeting secondary device patency [Срок оценки: Procedure/surgery through registry completion, anticipated average of 5 years]

Критерии участия

Критерии включения

• Willing, and able to provide legally-effective written informed consent (as required by Institutional Review Board or Ethics Committee)
• Male and female patients that have undergone bypass, replacement or repair of the peripheral arteries, aorta, or carotid artery using the Intervascular Vascular Grafts and Patches (Intergard Standard, Hemashield, Intergard Silver, Intergard Synergy)
• Were at least 18 years of age at the time of the procedure
• Available records for data collection with a minimum of 3 years (36 months) of data/follow-up.

Критерии исключения

• Active infection in the region of device placement at the time of implantation of the Intergard Standard and Hemashield Vascular Graft or Patch.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 2 центра

• The Pennsylvania State University and The Milton S. Hershey Medical Center — Hershey
• Allegheny General Hospital — Pittsburgh

Франция · 1 центр

• CHU Dijon Bourgogne — Dijon

Испания · 1 центр

• Hospital Universitario de Navarra — Pamplona

Идентификаторы

NCT: NCT07322913 · VV-TMF-00090

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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